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School-Based Depression Prevention for Adolescents With ADHD

School-Based Depression Prevention for Adolescents With ADHD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04104841
Acronym
BEAMS
Enrollment
50
Registered
2019-09-26
Start date
2018-08-07
Completion date
2022-07-11
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, Depressive Symptoms

Brief summary

The purpose of this study is to develop a modified behavioral activation program in adolescents with ADHD to be implemented by school mental health providers in an urban, low-income school district. Subsequently the investigators will examine its effectiveness in reducing depressive symptoms and improving emotion regulation and reward responsivity, compared to usual care.

Detailed description

Children with ADHD are at elevated risk for depression in adolescence and young adulthood, and this comorbidity is associated with far greater impairment than either disorder alone, including higher rates of inpatient hospitalization and increased risk for suicidal ideation and behavior. Despite these adverse outcomes, existing evidence-based interventions for ADHD have not demonstrated effects in reducing depressive symptoms nor do established depression prevention programs work as well for adolescents with ADHD. Reward responsivity (RR) and emotion regulation (ER) are two key factors demonstrated to mediate the association between ADHD and depression and are thus key targets for prevention. In an effort to address the gap between access and utilization of mental health care, which is especially stark among adolescents with ADHD, the investigators aim to develop and test a modified behavioral activation prevention program \[Behaviorally Enhancing Adolescents' Mood in Schools (BEAM-S)\] that incorporates modules to directly target these purported mechanisms. In line with the Deployment-Focused Model of Intervention Development and Testing, the investigators will develop a program that can be easily implemented and sustainable in the high school setting as delivered by school mental health staff that reduces depression and improves overall functioning in adolescents with ADHD, by way of improving RR and ER. As a first step, the investigators will conduct focus groups with community stakeholders (e.g., school mental health providers, school administration, adolescents, parents, teachers) to develop an acceptable and sustainable selected and indicated prevention program for school staff to utilize. The investigators will then initially train school staff to deliver this prevention program via to pilot the intervention for implementation of the prevention program in a case series to evaluate preliminary feasibility. The investigators will then conduct a stage 1 RCT with a hybrid-type 1 implementation effectiveness design in three high schools where adolescents will be randomized to either the BEAM-S condition (n= 54) or treatment as usual (n = 54). Finally, qualitative and quantitative data from aims 1-3 will be used to prepare final procedures for a future large-scale effectiveness trial R01 (aim 4).

Interventions

BEHAVIORALBehaviorally Enhancing Adolescents' Mood in Schools

8-session modified behavioral activation intervention

BEHAVIORALUsual Care

Referral to school mental health provider, social worker, or community care.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Maryland, College Park
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Enrolled in a participating Baltimore City Public High School * DSM-5 Diagnosis of attention-deficit/hyperactivity disorder (ADHD) * Depressive symptoms above T=65 on the Children's Depression Inventory (CDI)

Exclusion criteria

* History of seizures or neurological problems * DSM-diagnosis of Pervasive Developmental Disorder * Full scale IQ below 70 * Current depressive symptoms or active suicidality at severe levels where more intensive services would be warranted

Design outcomes

Primary

MeasureTime frameDescription
Children's Depression Inventory, 2nd Edition (CDI-2)After the 8-week preventive interventionAdolescent and parent reported depressive symptoms

Secondary

MeasureTime frameDescription
Suicide Behavior QuestionnaireAfter the 8-week preventive interventionAdolescent reported suicidal thoughts and behaviors
Emotion Regulation ChecklistAfter the 8-week preventive interventionParent reported emotion dysregulation
Difficulties in Emotion RegulationAfter the 8-week preventive interventionAdolescent reported emotion dysregulation
Mirror Tracing Persistence TaskAfter the 8-week preventive interventionEmotion regulation behavioral task
Affective Reactivity IndexAfter the 8-week preventive interventionAdolescent and parent reported irritability
Reward Probability IndexAfter the 8-week preventive interventionMeasure of adolescent reported environmental reward
Behavioral Activation for Depression ScaleAfter the 8-week preventive interventionAdolescent reported measure of behavioral activation and avoidance
Balloon Analog Risk TaskAfter the 8-week preventive interventionPositive reinforcement
Impairment Rating ScaleAfter the 8-week preventive interventionParent- and teacher- report of global impairment
Tripartite Pleasure InventoryAfter the 8-week preventive interventionAdolescent reported reward responsiveness

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026